Achieving euglycemia can be hampered by episodes of hypoglycemia and glucose variability which can now be tracked by continuous glucose monitoring (“CGM”). CGM devices have been shown to be clinically accurate in recording hypoglycemia, and can be used to assess diurnal patterns of glycemia. However, a challenge inherent to analysis of this influx of data is to represent it in a clinically meaningful manner that enables efficient clinical action. There is a need for glucose reports that can provide standardized, efficient output to effectively guide therapeutic decision making. Key benefits of glucose reports include a consistent view of glucose trends and patterns over the day, and showing the detail that A1C cannot. The identification of patterns of hypoglycemia and glucose variability can aid by guiding how aggressively the treatment can be safely adjusted.
Although present glucose reports have provided a way to analyze the influx of data from CGM, decision-making based on those reports and analyses can still be a challenge. Computerized algorithms have been developed as a way to simplify and guide the decision-making process. In hospital settings, computerized algorithms have been shown to improve patient outcomes by maintaining tight glucose control without increasing hypoglycemic events. In a clinical setting, computerized algorithms have also aided clinicians in correctly identifying glycemic patterns, making therapeutic decisions to address patterns, and teaching staff and patients.
Hence those skilled in the art have identified a need for presenting large amounts of CGM data in a useful manner. A need has also been recognized for analyzing CGM data so that possible effects in treatment changes can be analyzed. Further, a need has been recognized for a report that provides an overview of the glucose history of a patient and how effective the present treatment has been. Yet another need is for a glucose-based report that presents an overview of the patient's glucose history on an hourly basis annotated by certain periods of the day so that decisions may be made about possible treatment modification. The invention fulfills these needs and others.
Abbreviations—As used herein, the following abbreviations stand for the indicated terms:                A1C=glycated hemoglobin        AGP=ambulatory glucose profile        AU70=area under 70 mg/dL (3.9 mmol/L)        CG=control grid        CGM=continuous glucose monitor        FOM=figure of merit        GCA=glucose control assessment        Gm=median glucose        Gv=glucose variability        ITS=insulin titration sensitivity        JDRF=a trademark of Juvenile Diabetes Research Foundation; i.e., JDRF International        LGA=low glucose allowance        LLG=likelihood of low glucose        MTT=margin to treat        SMBG=self-monitored blood glucose        TMS=therapy management system        TRP=treatment recommendation point        